Journal of Pain Research (Sep 2022)
The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study
Abstract
Jee Young Lee,1 Kyoung Sun Park,2 Suna Kim,3 Ji Yeon Seo,4 Hyun-Woo Cho,5 Dongwoo Nam,6 Yeoncheol Park,6 Eun-Jung Kim,7 Yoon Jae Lee,1 In-Hyuk Ha1 1Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 2Jaseng Clinical Research Center, Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 3Jaseng Clinical Research Center, Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea; 4Jaseng Clinical Research Center, Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Republic of Korea; 5Jaseng Clinical Research Center, Haeundae Jaseng Hospital of Korean Medicine, Busan, Republic of Korea; 6Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 7Department of Acupuncture & Moxibustion, College of Korean Medicine, Dongguk University Bundang Oriental Hospital, Seongnam, Republic of KoreaCorrespondence: In-Hyuk Ha, Jaseng Spine & Joint Research Institute, Jaseng Medical Foundation, 540, Gangnamdae-ro, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82-2-2222-2740, Email [email protected]: Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservative treatment for LSS.Patients and Methods: A multi-centered, pragmatic, parallel-group study will be conducted. In total, 98 patients will be recruited at seven institutes; recruitment began in May 2022. After two treatment sessions per week over a period of 12 weeks, follow-up assessments will be held at weeks 13, 25, and 53.Results: The efficacy of pharmacopuncture and conservative care will be pragmatically compared in patients radiologically diagnosed with LSS. Pain severity will be measured using the numeric rating scale and visual analog scale. Walking distance will also be evaluated. Patient-centered evaluations will include the Zurich Claudication Questionnaire, Short-Form 12 for Health-Related Quality of Life, EuroQoL 5 Dimension 5 Levels, and Patient Global Impression of Change.Conclusion: The results of this study will confirm the efficacy of pharmacopuncture in comparison to conventional non-surgical treatment and will thus facilitate the prioritization of patient-centered interventions for LSS.Trial registration: This study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).Keywords: LSS, constriction, non-surgical intervention, acupuncture, pragmatic clinical trial, protocol
